The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

Taiho Pharma logo

Taiho Pharma

Status and phase

Completed
Phase 3

Conditions

Breast Cancer

Treatments

Drug: UFT (uracil, tegafur) and tamoxifen
Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00152178
91023033

Details and patient eligibility

About

This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.

Enrollment

680 estimated patients

Sex

Female

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: * Age 20 to 65 * Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 11.0 g/dL * Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL * Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

680 participants in 2 patient groups

1
Experimental group
Description:
UFT (uracil, tegafur) and tamoxifen
Treatment:
Drug: UFT (uracil, tegafur) and tamoxifen
2
Active Comparator group
Description:
CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen
Treatment:
Drug: CMF(cyclophosphamide, methotrexate, fluorouracil) and tamoxifen

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems